Alexion Pharmaceuticals, Inc. (Nasdaq: ALXN) today announced financial results for the quarter ended March 31, 2010.
“The recent approval of Soliris in Japan, as well as the completion of enrollment in our four trials in patients with aHUS, underscore our ongoing commitment to meet the needs of patients suffering from severe life-threatening ultra-rare diseases on a global level.”
First Quarter 2010 Financial Results:
For the three months ended March 31, 2010, Alexion Pharmaceuticals, Inc. ("Alexion" or the "Company") reported total revenues of $117.6 million from net product sales of Soliris® (eculizumab), reflecting steady additions of new patients, compared to $81.3 million for the year-ago quarter, Q1 2009. Net product sales in Q1 2010 increased by $7.0 million compared to $110.6 million in Q4 2009.
Soliris, approved by the U.S. Food and Drug Administration (FDA) and the European Commission in 2007, is the only drug specifically indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH), an ultra-rare, debilitating and life-threatening blood disorder.
Alexion's non-GAAP operating results are equal to GAAP operating results less only share-based compensation and non-cash tax expense. Non-cash tax expense represents the reduction in cash taxes primarily attributable to the utilization of U.S. net operating losses. The following summary table is provided for investors' convenience. A complete reconciliation of the GAAP to non-GAAP figures appears below.
(Thousands of U.S. dollars, except per-share data)
First Quarter 2010 Non-GAAP Financial Results:
The Company reported non-GAAP net income for Q1 2010 of $34.6 million, or $0.37 per share, an increase of 54 percent compared to non-GAAP net income of $22.4 million, or $0.25 per share, in Q1 2009.
Alexion's non-GAAP operating expenses for Q1 2010 were $65.2 million, compared to $47.8 million for Q1 2009. Non-GAAP research and development (R&D) expenses for Q1 2010 were $20.3 million, compared to $16.9 million for Q1 2009. The increase in R&D expenses primarily reflected the expansion of the Company's clinical trial programs. Non-GAAP selling, general and administrative (SG&A) expenses for Q1 2010 were $44.9 million, compared to $31.0 million for Q1 2009. The increase in non-GAAP SG&A expenses primarily reflected costs associated with the expansion of the Company's commercial operations worldwide, including costs associated with Japan operations.
First Quarter 2010 GAAP Financial Results:
Alexion reported GAAP net income of $20.9 million, or $0.23 per share, for Q1 2010, an increase of 44 percent compared to $14.5 million, or $0.16 per share, in Q1 2009.
On a GAAP basis, operating expenses for Q1 2010 were $73.0 million, compared to $55.7 million for Q1 2009. GAAP R&D expenses for Q1 2010 were $22.4 million, compared to $19.1 million for Q1 2009. GAAP SG&A expenses were $50.6 million for Q1 2010, compared to $36.7 million for Q1 2009.
As of March 31, 2010, the Company had $204.7 million in cash, cash equivalents and marketable securities, compared to $176.2 million at December 31, 2009.
"In the first quarter, we continued to provide Soliris to a steadily growing number of patients in the U.S. and Europe while expanding our global reach and advancing our pipeline programs," said Leonard Bell, M.D., Chief Executive Officer of Alexion. "The recent approval of Soliris in Japan, as well as the completion of enrollment in our four trials in patients with aHUS, underscore our ongoing commitment to meet the needs of patients suffering from severe life-threatening ultra-rare diseases on a global level."
On April 16, 2010, Alexion announced that Japan's Ministry of Health, Labour and Welfare (MHLW) approved the Company's New Drug Application (J-NDA) for Soliris as a treatment for patients with PNH in Japan. With the approval of the J-NDA, Alexion is now working with the MHLW to facilitate patient access to Soliris. The Company continues to anticipate a commercial launch of Soliris in Japan by the end of 2010.
First Quarter 2010 Research and Development Progress:
During the first quarter, Alexion made significant progress on advancing the development of Soliris as a treatment for patients suffering from additional rare and severe complement-mediated disorders. There are currently 12 clinical trials underway with Soliris in eight diseases, and the Company is increasingly focused on its two lead areas of nephrology and transplant.
Nephrology: Atypical Hemolytic Uremic Syndrome (aHUS)
In April 2010, Alexion announced completion of enrollment in its four clinical studies to investigate Soliris as a treatment for patients with atypical hemolytic uremic syndrome, or aHUS. The 26-week trials include both adults and adolescents. Preliminary data from the trials are expected to be presented toward the end of 2010. In addition, Alexion is working with regulatory authorities in the U.S. and European Union to finalize protocols for studies of Soliris in patients younger than 12 years of age. The Company expects to begin a trial in pediatric aHUS patients in mid-2010.
Transplant: Acute Humoral Rejection (AHR)
Soliris is being investigated as a treatment for patients undergoing kidney transplant who are at elevated risk of antibody mediated rejection, also known as acute humoral rejection, or AHR. It is anticipated that further interim data from an investigator-initiated trial at the Mayo Clinic will be presented at key congresses and published in a peer-reviewed journal later this year. The Company is supporting additional investigator-initiated studies in elevated-risk kidney transplantation in the U.S. and Australia.
Alexion's oncology program remains on track with patient enrollment and dosing in a clinical study of samalizumab, Alexion's novel anti-CD200 antibody, in patients with B-cell chronic lymphocytic leukemia (B-CLL). Preliminary data from this study were presented at the Targeted Anticancer Therapies conference in Maryland in March 2010. Dosing with samalizumab has also begun in patients with multiple myeloma.
2010 Financial Guidance:
The Company is reiterating its previously announced 2010 financial guidance. In 2010, worldwide net product sales are expected to be within a range of $505 to $520 million. Excluding share-based compensation, R&D expenses are anticipated to be in the range of $95 to $100 million and SG&A expenses in the range of $185 to $195 million. Cost of sales are anticipated to be in the range of 12 percent to 13 percent. The Company's share-based compensation expenses for the year are expected to be in a range of approximately $32 to $34 million. GAAP taxes are expected to be in the range of 30 percent to 32 percent. Non-GAAP taxes, which exclude non-cash tax expense, are expected to be in the range of 11 percent to 12 percent. Based on this expected non-GAAP tax rate and a forecast of 94 million fully diluted shares outstanding for 2010, Alexion is reiterating non-GAAP earnings per share guidance of $1.60 to $1.65.
Alexion Pharmaceuticals, Inc.